05-12498. Government-owned Inventions; Availability for Licensing and Cooperative Research and Development Agreements (CRADAs)

AGENCY:

Centers for Disease Control and Prevention, Technology Transfer Office, Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

The invention named in this notice is owned by agencies of the United States Government and is available for licensing in the United States (U.S.) in accordance with 35 U.S.C. 207, and is available for cooperative research and development agreements (CRADAs) in accordance with 15 U.S.C. 3710, to achieve expeditious commercialization of results of federally funded research and development. A U.S. provisional patent application has been filed and foreign patent applications are expected to be filed within the year to extend market coverage for U.S. companies and may also be available for licensing.

ADDRESSES:

Licensing and CRADA information, and information related to the technology listed below, may be obtained by writing to Suzanne Seavello Shope, J.D., Technology Licensing and Marketing Scientist, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Mailstop K-79, 4770 Buford Highway, Atlanta, GA 30341, telephone [phone]; facsimile [phone]; or e-mail [e-mail]. A signed Confidential Disclosure Agreement (available under Forms at http://www.cdc.gov/​tto) will be required to receive copies of unpublished patent applications and other information.

SOFTWARE—Family Healthware ^TM

Familial Risk Analysis for Determining a Disease Prevention Plan

Family health history reflects the interactions of genetic, environmental, and behavioral risk factors and has been shown to help predict disease risk for a variety of disorders including cardiovascular disease, cancer, and diabetes. The Centers for Disease Control and Prevention has an ongoing initiative to evaluate the use of family history information for assessing risk for common diseases and influencing early detection and prevention strategies. The tools and methods currently used for taking family histories, however, are inadequate for widespread use in preventive medicine and public health. As part of the family history initiative, CDC is developing an electronic, self-administered, Web-based tool that assesses familial risk for six diseases and recommends early detection and prevention strategies. The tool collects:

• Name, date of birth, gender, adoption status, Ashkenazi Jewish heritage.
• Current height and weight.
• Health behaviors: smoking, physical activity, fruit and vegetable consumption, alcohol use, aspirin use.
• Screening tests: clinical breast exam, mammogram, fecal occult blood test, sigmoidoscopy, colonoscopy, blood cholesterol, blood pressure, and blood sugar.
• Disease history of a person's first- and second-degree relatives (mother, father, grandparents, siblings, aunts and uncles) for coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer.

Algorithms in the software analyze the data and assess risk based on the number of relatives affected, their age at disease onset, their gender, the closeness of the relatives to each other and the user, and the combinations of diseases in the family. The tool provides the user with a report that includes an assessment of familial risk for each disease (described as strong, moderate or weak), an explanation as to why the family history is a risk factor, and recommendations for disease prevention and screening that are targeted to the familial risk and based on answers to the health behavior and screening questions. An evaluation trial of Family Healthware^TM; set in primary practice clinics will begin in July 2005.

Inventors: Maren T. Scheuner, Paula W. Yoon, Muin J. Khoury, and Cynthia Jorgensen.

CDC Ref. #: I-004-04.

Dated: June 13, 2005.

James D. Seligman,

Associate Director for Program, Services, Centers for Disease Control and Prevention.